title: Rationale and design of the COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 trial): a randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation.
abstract: BACKGROUND
  The efficacy and safety of colchicine for the primary prevention of the postpericardiotomy syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively.
  
  
  METHODS
  The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing <70 kg or intolerant to the highest dose). The primary efficacy end point is the incidence of PPS, postoperative effusions, and POAF at 3 months after surgery. Secondary end points are the incidence of cardiac tamponade or need for pericardiocentesis or thoracentesis, PPS recurrence, disease-related admissions, stroke, and overall mortality.
  
  
  CONCLUSIONS
  The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.
authors.affiliation: Cardiology Department and Pharmacology Unit, Maria Vittoria Hospital, Torino, Italy. massimo_imazio@yahoo.it
authors.forename: Massimo
authors.initials: M
authors.lastname: Imazio
authors.forename: Riccardo
authors.initials: R
authors.lastname: Belli
authors.forename: Antonio
authors.initials: A
authors.lastname: Brucato
authors.forename: Paolo
authors.initials: P
authors.lastname: Ferrazzi
authors.forename: Davide
authors.initials: D
authors.lastname: Patrini
authors.forename: Luigi
authors.initials: L
authors.lastname: Martinelli
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Polizzi
authors.forename: Roberto
authors.initials: R
authors.lastname: Cemin
authors.forename: Anna
authors.initials: A
authors.lastname: Leggieri
authors.forename: Alida L P
authors.initials: AL
authors.lastname: Caforio
authors.forename: Yaron
authors.initials: Y
authors.lastname: Finkelstein
authors.forename: Brian
authors.initials: B
authors.lastname: Hoit
authors.forename: Bernhard
authors.initials: B
authors.lastname: Maisch
authors.forename: Bongani M
authors.initials: BM
authors.lastname: Mayosi
authors.forename: Jae K
authors.initials: JK
authors.lastname: Oh
authors.forename: Arsen D
authors.initials: AD
authors.lastname: Ristic
authors.forename: Petar
authors.initials: P
authors.lastname: Seferovic
authors.forename: David H
authors.initials: DH
authors.lastname: Spodick
authors.forename: Yehuda
authors.initials: Y
authors.lastname: Adler
mesh_terms: D001281:Atrial Fibrillation / Q000209:etiology / Q000517:prevention & control*; D003078:Colchicine / Q000627:therapeutic use*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D010490:Pericardial Effusion / Q000209:etiology / Q000517:prevention & control*; D010492:Pericardiectomy / Q000009:adverse effects*; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control; D011322:Primary Prevention / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D013577:Syndrome; D050257:Tubulin Modulators / Q000627:therapeutic use
chemical_list: D050257:Tubulin Modulators; D003078:Colchicine